A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging

A—HUMAN NECESSITIES

A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE

A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR

A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests

B01L3/021—Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids

B01L3/0217—Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids of the plunger pump type

Abstract

A blood separation kit including: (a) a hollow elongated reservoir (10) having a first end and a second end and including a first hole (14) mounted at said first end to receive liquid or expel liquid from said reservoir (10), said hole (14) being closed, unless it is opened, by an adapter attached to said hole; (b) a plunger (20) disposed movably within and engaging the walls of said reservoir (10) of (a), said plunger (1) including a passage (22) through said plunger communicating with the interior of said reservoir of (a), and (2) a second hole (24) for expelling liquid mounted within said passage of (b) (1), said hole (24) being closed, unless open, by an adapter attached to said hole; and (c) a piston rod (26) having a passage and adapted to engage said piston of (b), said piston rod (1) including means for engaging said piston in order to provide communication with the interior of the - tank (10) of (a) by means of the passage (22) in the piston of (b) to the passage in said piston rod (26), (2) a third hole (30) for expelling liquid mounted in the end of said plunger rod in front of said means for engaging said plunger, said third hole (30) being closed, unless it is opened, by an adapter attached to said third hole.

Description

Syringe kit with platelet concentration and
process.

Field of the Invention

This invention relates to processing blood.
whole in fractions and, more particularly, to improvements in systems of
blood processing to separate blood platelet rich plasma
autologous

Background of the invention

The science and effectiveness of using rich plasma
in platelets derived from the patient's own blood in surgery
They are documented in medical, commercial and scientific journals.
A known method for the preparation of blood platelets
whole is described in the American Association of Blood Bank's
Technical Manual, 12th edition, 1996, pages
700-701, method 9.11. A system that uses this
method collects the patient's whole blood in a unit of
collection with two transfer tanks joined together. The
blood is collected in the collection tank, the other two
transfer deposits are crushed, and the two deposits of
transfer with the collection deposit undergo a
"smooth rotation" in a centrifuge, which puts the plasma in the
top of the collection unit, leaving red blood cells in
the bottom. In the next step, the collection deposit
containing the fractions of blood is compressed in an extractor
plasma to expel platelet rich plasma to one of the
transfer tanks through a connection tube. A
fraction including red blood cells remains behind in the reservoir
collection, which is then removed. Then both
transfer tanks, the first one being empty and containing
the second plasma, undergoes a "strong rotation" in a
centrifuge to concentrate platelets in the "bottom" of the second
transfer tank, leaving a fraction of the plasma poor in
platelets (PPP) above the platelet concentrate (PC) in the
Second transfer deposit. The next step compresses the
second transfer deposit to eject the PPP to the first
transfer deposit. The platelet concentrate (PC) is
Resuspend then and collect for use. This system uses a process
which requires six separate steps, including two steps of
centrifugation and two separation steps. The terms "rotation
smooth "and" strong rotation "are defined in the table
10.5-1, page 716 of the AABB Technical Manual.

An alternative method of separating fractions of
blood is explained in U.S. Patent No. 5,102,407
and it is called the "Amsterdam" method. Instead of two
rotations, soft and then strong, as explained
previously, a single strong rotation is used in which
they separate three fractions, that is, a relatively free plasma from
platelets, red blood cells, and a "beige" intermediate layer that
It contains platelets and leukocytes.

A medical device configured to be used in
The centrifuge is described in DE 44 45 030 A1. The device consists of
a hollow cylindrical body, which has a conical reducing end,
It fits in a standard centrifuge. A plunger can catch
mobile with the inner surface of the body. The plunger
It includes a central hole and can be extracted hooked to a
piston rod. The central hole and a central hole in the
piston rod form a passage from inside the body to
free end of the piston rod. The piston rod of
Piston can be closed with a cap while using on the
centrifuge

The usual procedures often employ
foldable plastic bags that make it difficult to separate exactly
blood fractions Consequently, improvements are needed. The
The present invention is carried out in a new separation kit
blood that provides more convenient and efficient means
to separate blood from a patient and in particular to recover
platelets

Summary of the Invention

The invention provides a kit according to the
claim 1 and a method according to claims 4 or 5.
one embodiment, the system is in the form of a syringe kit
including disposable components supplied in sterile package
disposable, and it has all the necessary components to
draw blood from the patient, avoid blood clotting,
separate the sample into fractions including concentrate of
platelets, and supply platelet concentrate to a place
surgical. A more exact separation of the fractions is possible
of separated blood, compared to the results achieved with
foldable plastic bags. Such a system will be useful for
Medical and dental professionals.

The invention can be described in general.
stating that it includes an elongated tank, preferably
cylindrical, which is adapted to be placed in a centrifuge to
separate the fractions of blood introduced into the reservoir. He
tank is equipped with a first hole through which the
blood fractions can be ejected by a piston mounted from
mobile form inside the warehouse. The first hole is located in
a first end of the tank and a second hole is located in
the mobile piston Both holes are normally closed and are
open from outside the tank as required for removal of
blood fractions The piston is equipped with a rod of
separable hollow plunger adapted to open the second hole
when the piston rod is attached to the piston. A third hole
is mounted on the end of the piston rod, the third
hole is also normally closed unless it is opened from
out of the piston rod.

In one embodiment of the invention, the deposit
It is shaped like a syringe barrel fitted with a mobile piston. He
syringe barrel is loaded with a patient's blood and all
centrifugation and separation steps are performed while the blood
It's in that deposit. The syringe barrel is adapted for use
in a centrifuge, and it has valves mounted at one end and inside
of the plunger, making it possible to collect blood, centrifuge the blood
in the syringe barrel, expel red blood cells after the
smooth or first rotation, centrifuge platelet rich plasma
remaining and expel platelet poor plasma after rotation
strong or second. The platelet concentrate (PC) remains in the
syringe barrel, where it can be resuspended in a medium or media
that can be introduced into the deposit through one of the
valves

In another embodiment, the reservoir of the invention
receives a "strong" rotation, omitting the rotation
"soft". Three fractions are formed; the first fraction, the
red blood cells, is expelled through the first hole; to
then the second fraction, platelet-poor plasma, is
ejected through the second and third holes, leaving the
third layer, consisting of platelets and plasma, for processing
additional.

The separation of blood fractions can be
carry out manually after centrifuging whole blood
In the deposit. Alternatively, the separation of fractions of
blood could be carried out automatically in centrifugal equipment
which has facilities to open the holes after having
determined that the desired separation has been carried out.

With the deposit it will preferably be associated
a needle set to draw blood from a patient and that is
adapted to transfer blood to the syringe tank
directly or to a separate deposit for later transfer
to the syringe tank. One or more waste bags adapted for
receive platelet-poor plasma and red blood cells from the cylinder
syringe after smooth and strong rotations can be part
of the syringe kit.

Brief description of the drawings

Figure 1 is an isometric view of a
elongated syringe tank and associated components.

Figure 2 is a longitudinal section view
through figure 1.

Figure 3 depicts a collection needle of
blood.

Figure 4 represents a bag of
waste.

Figures 5a to 5e show the use of the
syringe production to prepare platelet concentrate.

Description of the illustrative embodiments

The figures illustrate a syringe embodiment
of the invention adapted for manual operation in the separation of
blood fractions The extracted blood is introduced into a syringe
of a patient, the syringe is placed in a centrifuge and rotates to the
appropriate speed for a suitable period of time to do
Let the blood separate into at least two fractions.
Alternatively, the separation can be automated and the
Blood fractions can be separated without manual handling of the
syringe tank Figure 1 represents an elongated tank
10, which bears graduated marks 12 to indicate the volume of its
content (not shown). The tank has a first hole,
represented in the drawing including a ball seat valve
pushed by spring 14, at a first end 16 and a flange
radial 18 at its other end. A plunger 20 slides fit
inside the tank and prevents blood from passing between the wall of the
reservoir and plunger. The plunger has a passage 22 provided as a
second hole, also represented as a seat valve
ball driven by spring 24 (figure 2). The valve 24 could be
omit, if desired, in which case it would be necessary to temporarily seal
the hole while the tank is being centrifuged to
separate the fractions of blood. A tubular piston rod 26
is adapted at one end 28 to engage the seat valve
ball driven by spring 24. The piston rod has another
spring-loaded ball seat valve 30 on its other
far end of the plunger. Valves 14, 24 and 30 may have a
"Luer" adapter, which has a coupling 15, 25 and 31,
respectively, to connect removably with another item (for
example, a hose). This type of valve is normally
closed when nothing is connected to its coupling, and the valve
can be opened when the protruding element of a connector
coupling moves the ball away from the valve seat. It should
understand that the valves don't have to be the seat valves
of ball pushed by spring represented in the drawings, but
they may be other types capable of preventing the escape of
components of the blood and of opening when necessary, by
for example a valve in which a silicone plunger makes a
hermetic seal against a conical valve seat, whose
compression closes the valve until it is activated. In more terms
In general, the holes may include other means to block
the flow of blood components rather than the valves in
the figures.

Tank 10 and the associated parts of the kit,
in particular the piston 20 and piston rod 26, differ from the
conventional folding plastic bags in which they are made of
relatively rigid materials, for example polycarbonate,
polypropylene, ABS or equivalent. An advantage of the present
invention is that, since the tank walls are
relatively rigid, problems associated with separating are avoided
blood fractions in a folding bag. The movement of
piston inside the tank creates minimal disturbance of the layers of
separate blood, allowing for more separation
exact.

Figure 3 represents a needle 32 to take
blood of a patient connected to one end of a tube 34 that
it has at its other end an adapter 36 that is adapted to
connection to any of the couplings 15, 25 or 31. Thus, it can be
introduce blood directly into the reservoir 10 through the
valve 14 or, alternatively, the blood can be directed to a
separate bag for later transfer to the deposit for
separation.

Figure 4 represents a waste bag 40,
typically, but not necessarily, a plastic bag
folding, connected to one end of a tube 42 that has on its other
end an adapter 44 that is adapted for connection to
any of the couplings 15, 25 or 31, thereby opening the
associated valve. The tube 42 is provided with a tube clamp 46.
The tank 10 and the associated parts represented in the figures
1-4, inclusive, include this syringe kit
embodiment of the invention. Deposit 10, devoid of
associated parts (piston rod 26, needle 32 and tube 34, and bag
of waste 40 and tube 42) may be adapted to fit in a
centrifuge bucket (not shown) and used to separate blood in
their fractions and to prepare platelet concentrate, as
describe with reference to figures 5a-5e,
inclusive.

In Figure 5a, the plunger 20 is in the part
upper of the tank 10, near the flange 18, the needle 32 is
connected to a check valve 14, which is kept open, the
waste bag 40 is connected to the check valve of
plunger 24 that holds the valve open, and the clamp 46 is
open The tank may be empty or it may contain a small
amount of a blood anticoagulant. When the needle 32 removes
blood of the patient, blood flows to the pressure vessel from the
patient, displacing air from reservoir 10, air received
in the waste bag 40. When the tank 10 is loaded with
blood, waste bag 40 and needle 32 are decoupled from the
valves 14 and 24, which are closed by the associated springs.
Alternatively, the waste bag 40 is not used and instead
you can use plunger 20 to draw blood directly from the
patient similar to a conventional syringe. The deposit
undergoes a slight rotation in a centrifuge (not
represented). As depicted in Figure 5b, this step separates
red blood cells (pRBC) of platelet rich plasma (PRP). In step
Next, represented in Figure 5c, the waste bag is
connects to a valve 14, and the piston rod 26 connects to the
piston through valve 24. Valves 14 and 24 and the caliper
the waste bag 46 is open, but the valve 30 in the
free end of the piston rod is closed. The stem of
piston 26 is used to push the plunger into the reservoir, expelling the
red blood cells to waste bag 40. The tank now contains
primarily platelet rich plasma. The clip 46 closes, and the
piston rod and waste bag 40 are decoupled from the
tank, closing valves 14 and 24.

Deposit 10, devoid of the bag and the
piston rod, as shown in figure 5d, is subjected
after a strong rotation, which concentrates platelets in the
lower end 16 of reservoir 10, leaving poor plasma in
Platelets (PPP) above the platelet concentrate. The final step
of the process, to remove the platelet-poor plasma from
deposit, illustrated in figure 5e. The piston rod 26 joins
back to the plunger 20, and the waste bag 40 is coupled to the
free end of the piston rod through valve 30. The
valves 24 and 30 and clamp 46 are open, and valve 14 is
closed. The plunger moves towards the lower end 16 of the
deposit, and platelet-poor plasma is expelled through the
passage in the piston rod 26 and the tube 44 to the bag
waste. The clamp 46 is subsequently closed, and the bag of
waste 40 and, if desired, the piston rod 26 can be removed
of the deposit. With the waste bag removed, the
piston rod valve 30, so as not to remove the stem from
Plunger will not affect the contents of the deposit. Deposit 10 is
leave now with the platelet concentrate in it.

The above description covers a simple
manual operation in which the syringe kit is used in a way
particular to separate blood into three fractions by successive
smooth and strong rotations. It is also possible to use only one
"strong" rotation to separate blood in a single step in
three fractions (i.e. red blood cells, plasma and a layer
intermediate containing platelets). The three fractions can be
separate by expelling plasma and red blood cells separately or
simultaneously, leaving the intermediate layer for processing
additional. Alternatively, such manual operations can be
automate.

It should be understood that the syringe kit before
described is a preferred embodiment, but that can be done
modifications without departing from the scope of the defined invention
by the following claims.

Claims (7)

1. A blood separation kit
including:

(a) a hollow elongated tank (10) having a
first end and a second end and including a first hole
(14) mounted on said first end to receive liquid or expel
liquid from said tank (10), said hole being closed
(14), unless it is opened, by an adapter attached to said
orifice;

(b) a plunger (20) disposed in a mobile manner
inside and hooking the walls of said tank (10) of (a),
including said plunger

(one)

a
step (22) through said plunger that communicates with the interior of
said deposit of (a), and

(2)

a
second hole (24) for expelling liquid mounted inside said
step of (b) (1), said hole (24) being closed, unless
open, by an adapter attached to said hole; Y

(c) a piston rod (26) that has a passage
and adapted to engage said plunger of (b), including said
piston rod

(one)

means for engaging said plunger with
in order to provide communication with the inside of the tank
(10) of (a) by step (22) in the plunger of (b) to the step in
said piston rod (26),

(2)

a
third hole (30) for expelling liquid mounted at the end of
said plunger rod in front of said means for engaging
said plunger, said third hole (30) being closed, unless
that opens, by an adapter attached to said third
orifice.

2. A blood separation kit from the
claim 1, further including:

(d) a needle set including:

(one)

a
hollow needle (32) to take a blood sample from a
patient;

(2)

a
hollow tube (34) attached to and communicating with said needle for
transfer said patient's blood to the reservoir of (a); Y

(3)

a
adapter (36) adapted to engage the first hole of (a) and
open said first hole.

3. A blood separation kit from
claims 1 or 2, further including:

(e) a waste bag (40) that has a tube
gap (42) connected to and communicating with the interior of said
bag to receive separate blood fractions;

(f) an adapter (44) adapted to engage
the first and third holes (a) and (c) (2) respectively and for
open said first and third holes; Y

(g) a clamp (46) mounted on the tube of (e)
to open and close the hollow tube (42) of (e).

4. A method of separating blood and recovering a
platelet rich concentrate including:

(a) centrifuge an elongated tank filled with
blood (10) having a first part and provided with a plunger
mobile that has a second hole (24) in it; and separate said
plasma blood rich in platelets and red blood cells;

(b) move the red blood cells apart in
(a) of said reservoir by moving said plunger (20) towards said first
hole (14) and expel said red blood cells into a bag of
waste (40) through a tube (42) attached to said first
orifice;

(c) remove said waste bag (40) from (b)
centrifuging said platelet rich plasma that remains in said
deposit (10) and separating a platelet-rich concentrate from a
platelet poor plasma;

(d) join a hollow plunger rod (26) that
has a third hole (30) to said plunger and displace the plasma
poor in platelets separated in (c) of said deposit by moving said
plunger towards said first hole (14) and expelling said plasma
poor in platelets through said second hole (24) of said
plunger and said third hole of said plunger rod to a
waste bag (40) attached to the piston rod; Y

(e) recover platelet rich concentrate
separated in (c) and remaining in said deposit.

5. A method of separating blood and recovering a
platelet rich concentrate including:

(a) centrifuge an elongated tank filled with
blood (10) having a first hole and provided with a plunger
mobile that has a second hole (24); Y

(c) move the red blood cells apart in
(a) of said reservoir by moving said plunger (20) towards said first
hole (14) and expelling said red blood cells to a bag of
waste (40) through a tube attached to said first hole
(14);

(d) remove said waste bag (40) from (b) and
joining a hollow plunger rod (26) that has a third hole
(30) to said plunger and displace platelet-poor plasma
separated in (a) from said reservoir by moving said plunger towards said
first hole (14) and expel said platelet-poor plasma to
through said second hole (24) of said plunger and said
third hole of said piston rod to a waste bag
attached to the piston rod; Y

(e) recover platelet rich concentrate
separated in (a) and remaining in said deposit.

6. A blood separation kit of at least
one of claims 1 to 3, wherein said holes first,
second and third include valves placed not to expel
blood fractions during blood centrifugation in said
Deposit.

7. A blood separation kit of at least
one of claims 1 to 3 or 6, wherein said holes
Luer adapters included.

ES00945212T1999-07-082000-07-07Syringe kit with concentration of plates and procedure.
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